Feasibility Usability & Acceptability Study: Symptom Reporting by Children Adolescents & Young Adults w/Cancer

N/AActive Not RecruitingNCT06824441

Stanford University85 enrolled

Overview

The purpose of this project is to pilot test an electronically delivered symptom assessment tool Pediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (Ped-PRO-CTCAE), completed by children/adolescents and young adults (AYAs) and caregivers and shared with their clinicians during an outpatient clinic visit, in preparation for a future test of intervention efficacy.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Adolescent Behavior Pediatric Cancer Oncology

Interventions

Age- and Role-Specific Questionnaire AdministrationBEHAVIORAL

Participants will be assigned a sequence number upon eligibility confirmation. The intervention consists of completing a series of questionnaires, as follows: Child/AYA/Caregiver Group: Pre-clinic Visit: 3 questionnaires (approximately 15-20 minutes total). Post-clinic Visit: 2 questionnaires (approximately 5-10 minutes total). Clinician Group: Post-clinic Visit: 2 questionnaires (approximately 5 minutes total).

Eligibility

Sex: ALLMin age: 7 YearsMax age: 21 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. First diagnosis of cancer 2. Receiving cancer therapy: surgery, myelosuppressive chemotherapy and/or radiation 7-21 years of age 3. Completed at least 1 month of cancer chemotherapy treatment and are within 7-28 days of starting a treatment cycle or during ongoing therapy, followed at least every month in clinic 4. If surgery was part of treatment, the patient must be 3-6 weeks post surgery before participating in study 5. Caregiver must be present and 18 years and older 6. Ability to understand and the willingness to personally sign the written IRB-approved informed consent or assent document as appropriate 7. Disease can be newly diagnosed, in relapse or refractory, as long as this is the first diagnosis of cancer 8. Child must be able to read or listen to and understand English Exclusion Criteria: 1\. Child must not have cognitive/memory impairments determined by the child's clinician

Locations (1)

Stanford University

Palo Alto, California, United States

Outcomes

Primary Outcomes

Feasibility of Utilizing Ped-PRO-CTCAE for Clinician Access to Child/AYA and Caregiver Proxy Symptom Reports During Clinic Visits

To determine the feasibility of providing clinicians with child/AYA and caregiver (proxy) subjective symptom reports using the validated Ped-PRO-CTCAE items during a clinic visit.

Time frame: 1 year

Evaluation of Usability and Acceptability of Child/Adolescent and Caregiver Symptom Reports (Ped-PRO-CTCAE) for Clinicians in an Outpatient Oncology Clinic Setting

To evaluate the usability and acceptability of providing the child/adolescent and caregiver symptom reports (Ped-PRO-CTCAE) to the clinician in an outpatient oncology clinic setting

Time frame: 1 year

Analysis of Symptom-Related Outcome Variables to Inform Sample Size Calculations for a Future Randomized Clinical Trial of the Ped-PRO-CTCAE Intervention

To describe and analyze symptom-related outcome variables that will assist in sample size calculations for a future randomized clinical trial of the Ped-PRO-CTCAE intervention.

Time frame: 1 year

Data from ClinicalTrials.gov

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